HEPARIN COATED THERMODILUTION CATHETER

HEPARIN COATED THERMODILUTION CATHETER is an FDA 510(k)-cleared medical device (K821235) manufactured by Gould, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 17, 1982. Regulation: 8.